The Clots in Legs or sTockings after Stroke (CLOTS) 3 trial: A randomised controlled trial to determine whether or not intermittent pneumatic compression reduces the risk of post-stroke deep vein thrombosis and to estimate its cost-effectiveness

Health Technology Assessment

Volumn 19, Issue 76, 2015, Pages 1-90

  Dennis, Martin ^a   Sandercock, Peter ^a   Graham, Catriona ^b   Forbes, John ^c  

^a UNIVERSITY OF EDINBURGH   (United Kingdom)

^b UNIVERSITY OF EDINBURGH   (United Kingdom)

^c UNIVERSITY OF LIMERICK   (Ireland)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CEREBROVASCULAR ACCIDENT; COMPRESSION SLEEVE; COMPRESSION STOCKING; COMPRESSION THERAPY; COST EFFECTIVENESS ANALYSIS; DEEP VEIN THROMBOSIS; ECHOGRAPHY; FOLLOW UP; HOSPITAL ADMISSION; HUMAN; IMMOBILITY; INTERMITTENT PNEUMATIC COMPRESSION; INTERMITTENT PNEUMATIC COMPRESSION DEVICE; LEG; MONITORING; MULTICENTER STUDY (TOPIC); OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK REDUCTION; SURVIVAL; SYSTEMATIC REVIEW (TOPIC); UNITED KINGDOM; AGED; CLINICAL TRIAL; COMPLICATION; CONTROLLED STUDY; COST BENEFIT ANALYSIS; ECONOMICS; FEMALE; HOSPITALIZATION; MALE; MIDDLE AGED; MORTALITY; MULTICENTER STUDY; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RISK FACTOR; TREATMENT OUTCOME; VENOUS THROMBOSIS;

AGED; COST-BENEFIT ANALYSIS; FEMALE; HOSPITALIZATION; HUMANS; INTERMITTENT PNEUMATIC COMPRESSION DEVICES; MALE; MIDDLE AGED; QUALITY OF LIFE; RISK FACTORS; STROKE; SURVEYS AND QUESTIONNAIRES; TREATMENT OUTCOME; UNITED KINGDOM; VENOUS THROMBOSIS;

EID: 84943192306     PISSN: 13665278     EISSN: 20464924     Source Type: Journal    
DOI: 10.3310/hta19760     Document Type: Article

References (50)

1. House of Commons Health Committee. The Prevention of Venous Thromboembolism in Hospitalised Patients. Second Report of Session 2004–05 Report, HC 99. London: The Stationery Office; 2005.
2. Kelly J, Rudd A, Lewis RR, Hunt BJ. Venous thromboembolism after acute stroke. Stroke 2001;32:262–7. http://dx.doi.org/10.1161/01.STR.32.1.262
3. The CLOTS Trials Collaboration. Can clinical features distinguish between immobile stroke patients at high and low risk of deep vein thrombosis (DVT)? Statistical modelling based on the CLOTS trials cohorts. J Neurol Neurosurg Psychiatry 2011;82:1067–73. http://dx.doi.org/10.1136/jnnp.2010.235945
4. Kelly J, Rudd A, Lewis RR, Coshall C, Moody A, Hunt BJ. Venous thromboembolism after acute ischemic stroke: a prospective study using magnetic resonance direct thrombus imaging. Stroke 2004;35:2320–5. http://dx.doi.org/10.1161/01.STR.0000140741.13279.4f
5. Dennis M, Mardi N, Graham C, Sandercock P for the CLOTS trials collaboration. The timing, extent, progression and regression of DVT in immobile stroke patients: observational data from the CLOTS randomized trials. J Thromb Haemost 2011;9:2193–200. http://dx.doi.org/10.1111/j.1538-7836.2011.04486.x
6. Sandercock PAG, Counsell C, Kamal AK. Anticoagulants for acute ischaemic stroke. Cochrane Database Syst Rev 2008;4:CD000024. http://dx.doi.org/10.1002/14651858.cd000024.pub3
7. Davenport RJ, Dennis MS, Wellwood I, Warlow CP. Complications following acute stroke. Stroke 1996;27:415–20. http://dx.doi.org/10.1161/01.STR.27.3.415
8. CLOTS Trials Collaboration. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS Trial 1): a multicentre, randomized controlled trial. Lancet 2009;373:1958–65. http://dx.doi.org/10.1016/S0140-6736(09)60941-7
9. Kelly J, Hunt BJ, Rudd A, Lewis RR. Pulmonary embolism and pneumonia may be confounded after acute stroke and may co-exist. Age Ageing 2002;31:235–9. http://dx.doi.org/10.1093/ageing/31.4.235
10. Warlow C, Ogston D, Douglas AS. Deep venous thrombosis of the legs after strokes. Part 1. Incidence and predisposing factors. Br Med J 1976;1:1178–81. http://dx.doi.org/10.1136/bmj.1.6019.1178
11. International Stroke Trial Collaborative Group. The International Stroke Trial (IST): a randomized trial of aspirin, subcutaneous heparin, both or neither among 19435 patients with acute ischaemic stroke. Lancet 1997;349:1569–81. http://dx.doi.org/10.1016/S0140-6736(97)04011-7
12. Lederle FA, Zylla D, MacDonald R, Wilt TJ. Venous thromboembolism prophylaxis in hospitalized medical patients and those with stroke: a background review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med 2011;155:602–15. http://dx.doi.org/10.7326/0003-4819-155-9-201111010-00008
13. Roderick P, Ferris G, Wilson K, Halls H, Jackson D, Collins R, et al. Towards evidence-based guidelines for the prevention of venous thromboembolism: systematic reviews of mechanical methods, oral anticoagulation, dextran and regional anaesthesia as thromboprophylaxis. Health Technol Assess 2005;9(49). http://dx.doi.org/10.3310/hta9490
14. Agu O, Hamilton G, Baker D. Graduated compression stockings in the prevention of venous thromboembolism. Br J Surg 1999;86:992–1004. http://dx.doi.org/10.1046/j.1365-2168.1999.01195.x
15. Naccarato M, Chiodo Grandi F, Dennis M, Sandercock PAG. Physical methods for preventing deep vein thrombosis in stroke. Cochrane Database Syst Rev 2010;8:CD001922. http://dx.doi.org/10.1002/14651858.cd001922.pub3
16. Muir KW, Watt A, Baxter G, Grosset DG, Lees KR. Randomised trial of graded compression stockings for prevention of deep vein thrombosis after acute stroke. QJM 2000;93:359–64. http://dx.doi.org/10.1093/qjmed/93.6.359
17. Morris R. Intermittent pneumatic compression – systems and applications. J Med Eng Technol 2008;32:179–88. http://dx.doi.org/10.1080/03091900601015147
18. Kohro S, Yamakage M, Sato K, Sato JI, Namiki A. Intermittent pneumatic foot compression can activate blood fibrinolysis without changes in blood coagulability and platelet activation. Acta Anaesthesiol Scand 2005;49:660–4. http://dx.doi.org/10.1111/j.1399-6576.2005.00661.x
19. Ho KM, Tan JA. Stratified meta-analysis of intermittent pneumatic compression of the lower limbs to prevent venous thromboembolism in hospitalized patients. Circulation 2013;128:1003–20. http://dx.doi.org/10.1161/CIRCULATIONAHA.113.002690
20. The CLOTS Trials Collaboration. Thigh-length versus below-knee stockings for DVT prophylaxis after stroke: a randomised trial. Ann Intern Med 2010;153:553–62. http://dx.doi.org/10.7326/0003-4819-153-9-201011020-00280
21. Counsell C, Dennis M, McDowall M, Warlow C. Predicting outcome after acute stroke: development and validation of new models. Stroke 2002;33:1041–7. http://dx.doi.org/10.1161/hs0402.105909
22. Altman DG, Bland JM. Treatment allocation by minimisation. BMJ 2005;330:843. http://dx.doi.org/10.1136/bmj.330.7495.843
23. Davidson BL. What are the most reliable detection methods for deep vein thrombosis and pulmonary embolism to be used as endpoints in trials of venous thromboprophylaxis? Haemostasis 1998;28:S113–19. http://dx.doi.org/10.1159/000022388
24. Galanaud JP, Sevestre-Pietri MA, Bosson JL, Laroche JP, Righini M, Brisot D, et al. OPTIMEV-SFMV Investigators. Comparative study on risk factors and early outcome of symptomatic calf versus proximal deep vein thrombosis: results from the OPTIMEV study. Thromb Haemost 2009;102:493–500. http://dx.doi.org/10.1160/TH09-01-0053
25. Kearon C. Natural history of venous thromboembolism. Circulation 2003;107:I-22–I-30. http://dx.doi.org/10.1161/01.CIR.0000078464.82671.78
26. Bamford JL, Sandercock PAG, Warlow CP, Slattery J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke 1989;20:828. http://dx.doi.org/10.1161/01.STR.20.6.828
27. EUROQoL Group. EUROQoL – a new facility for the measurement of health related quality of life. Health Policy 1990;16:199–208. http://dx.doi.org/10.1016/0168-8510(90)90421-9
28. Dolan P, Gudex C, Kind P, Williams A. A Social Tariff for EuroQol: Results from a UK General Population Survey. York: University of York; 1995
29. Dennis M, Sandercock P, Reid J, Graham C, Forbes J. Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: study protocol for a randomised controlled trial. Trials 2012;13:26. http://dx.doi.org/10.1186/1745-6215-13-26
30. Dennis M, Sandercock P, Murray G, Forbes J. Does intermittent pneumatic compression reduce the risk of post stroke deep vein thrombosis? The CLOTS 3 trial: statistical analysis plan. Trials 2013;14:66. http://dx.doi.org/10.1186/1745-6215-14-66
31. Schunemann HJ, Oxman AD, Gunn EV, Higgins JPT, Deeks JJ, Glasziou P, et al. Chapter 12: Interpreting Results and Drawing Conclusions. In Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. Cochrane, 2011. URL: http://hiv.cochrane.org/sites/hiv.cochrane.org/files/uploads/Ch12_Interpreting.pdf (accesssed 1 May 2013).
32. Buyse M, George SL, Evans S, Geller NL, Ranstam J, Scherrer B, et al. The role of biostatistics in the prevention, detection and treatment of fraud in clinical trials statist. Med 1999;18:3435–51.
33. CLOTS (Clots in Legs Or sTockings after Stroke) Trials Collaboration. Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): a multicentre randomised controlled trial. Lancet 2013;382:516–24. http://dx.doi.org/10.1016/S0140-6736(13)61050-8
34. Bembenek J, Karlinski M, Kobayashi A, Czlonkowska A. Early stroke-related deep venous thrombosis: risk factors and influence on outcome. J Thromb Thrombolysis 2011;32:96–102. http://dx.doi.org/10.1007/s11239-010-0548-3
35. Department for Health. NHS Reference Costs 2011–2012. London: Department of Health; 2013.
36. Information Services Division. Scottish Health Service Costs. Edinburgh: NHS Scotland; 2013.
37. StataCorp. Stata 12 Multiple-Imputation Reference Manual. College Station, TX: Stata Press; 2011.
38. Baio G. Bayesian Methods in Health Economics. London: CRC/Chapman & Hall; 2012. http://dx.doi.org/10.1201/b13099
39. The FOOD Trial Collaboration. Routine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial. Lancet 2005;365:755–63. http://dx.doi.org/10.1016/S0140-6736(05)70998-3
40. The FOOD Trial Collaboration. Effect of timing and method of enteral tube feeding for dysphagic stroke patients (FOOD): a multicentre randomised controlled trial. Lancet 2005;365:764–72. http://dx.doi.org/10.1016/S0140-6736(05)70999-5
41. R Development Core Team. R: A Language and Environment for Statistical Computing. Vienna: R Foundation for Statistical Computing; 2014. URL: www.R-project.org
42. Szende A, Oppe M, Devlin N, editors. EQ-5D Value Sets: Inventory, Comparative Review and User Guide. Dordrecht: Springer; 2007. http://dx.doi.org/10.1007/1-4020-5511-0
43. Scottish Stroke Care Audit. URL: www.strokeaudit.scot.nhs.uk/ (accesssed 9 April 2013).
44. Prasad BK, Banerjee AK, Howard H. Incidence of deep vein thrombosis and the effect of pneumatic compression of the calf in elderly hemiplegics. Age Ageing 1982;11:42–4 http://dx.doi.org/10.1093/ageing/11.1.42
45. Lacut K, Bressollette L, Le GG, Etienne E, De TA, Renault A, et al. Prevention of venous thrombosis in patients with acute intracerebral hemorrhage. Neurology 2005;65:865–9. http://dx.doi.org/10.1212/01.wnl.0000176073.80532.a2
46. Westendorp WF, Vermeij JD, Vermeij F, Hertog HMD, Dippel DWJ, van de Beek D, et al. Preventive antibiotics in acute stroke: summary of a Cochrane systematic review and meta-analysis. Stroke 2012;43:e113–14. http://dx.doi.org/10.1161/STROKEAHA.112.671420
47. NHS Improving Quality. Intermittent Pneumatic Compression (IPC) Sleeves Programme FAQ. Version 1. Leeds: NHS Improving Quality 2014. URL: www.nhsiq.nhs.uk/media/2463598/ipc_sleeves_faqs_v1_290514.pdf (accessed 4 July 2014).
48. Scottish Government. Stroke Improvement Plan 2014. URL: www.scotland.gov.uk/Publications/2014/08/9114 (accessed 1 September 2014).
49. Royal College of Physicians. Sentinel Stroke National Audit Programme. London: Royal College of Physicians. URL: www.rcplondon.ac.uk/projects/sentinel-stroke-national-audit-programme (accessed 1 September 2014).
50. Cohen AT, Agnelli G, Anderson FA, Arcelus JI, Bergqvist D, Brecht JG, et al. Venous thromboembolism (VTE) in Europe: the number of VTE events and associated morbidity and mortality. Thromb Haemost 2007;98:756–64. http://dx.doi.org/10.1160/th07-03-0212